Sequencing of Sipuleucel-T and ADT in Men With Non-metastatic Prostate Cancer

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

The main purpose of this study was to determine whether ADT started before or after sipuleucel-T led to a better immune system response. This study also evaluated the safety of sipuleucel-T and ADT treatment, immune system responses over time, the characteristics of sipuleucel-T, and changes in prostate specific antigen (PSA) values over time.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dendreon
• Treatments: Androgens; Leuprolide

Criteria

Inclusion Criteria:

• Hormone-sensitive prostate cancer

• Non-metastatic disease, as evidenced by negative bone scan or computed tomography of the abdomen and pelvis

• ECOG performance status ≤ 1

• Histologically documented prostate cancer

• Prior primary therapy for prostate cancer

• Rising PSA with a PSADT of ≤ 12 months

• Testosterone ≥ 200 ng/dL ≤ 28 days of registration

• Adequate hematologic, renal, and liver function

• Must live in a permanent residence within a comfortable driving distance (round-trip within one day) to the clinical research site

Exclusion Criteria:

• Requires systemic ongoing immunosuppressive therapy

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to sipuleucel-T or GM-CSF

• Prior sipuleucel-T therapy

• Prior ADT therapy ≤ 6 months prior to registration or ≥ 6 months duration in total

• If subject has a history of any other stage III/IV malignancy, the subject must be disease free and off any malignancy-related treatment for at least 10 years. If the subject has a history of any stage I-II malignancy, the subject must be disease free and off any malignancy-related treatment for at least 5 years.

• Prior experimental immunotherapy or on an experimental clinical trial within 1 year

• Received denosumab or XRT ≤ 6 months prior to registration

• Received chemotherapy or GM-CSF ≤ 90 days prior to registration

• Received any of the following medications or interventions ≤ 28 days prior to registration

• major surgery requiring general anesthesia

• systemic immunosuppressive therapy

• other prescription treatment for prostate cancer

• Active infection within 1 week of registration

• Likely to receive XRT or surgery for prostate cancer during the study period

• Any medical intervention, any other condition, or any circumstances that could compromise the study.